Clinical development can involve thousands of training assignments across hundreds of global personnel at sponsors, CROs, and research sites. Typically, each stakeholder uses a different method or system to train staff, as Shad Ayoub, senior director for study training at Veeva, explained in a breakdown of the flaws of the current approach.
“A sponsor might use an internal learning management system to train in-house study teams. The CROs partnering on the trial would use their own systems to train personnel. For research sites, CROs may use paper forms and trackers to train them on study processes and protocols during valuable site initiation visit time. Managing study training in this disconnected way makes it difficult to see training progress and even harder to collect and file evidence of completion,” said Ayoub.
Veeva has responded to the shortcomings of current systems by developing Veeva Vault Study Training, an application intended to serve as a single, end-to-end clinical trial training platform for all stakeholders. Ayoub sees the platform as making it easier to create, assign and deliver assignments and file evidence into Vault eTMF.
The platform is designed to enable companies to leverage existing clinical content to develop training and use current clinical master data and content to tackle redundant information, manual data entry, and siloed processes, issues that Veeva has identified as shortcomings of traditional approaches.
“Using siloed systems, processes, and paper forms to manage study training in a global study with dispersed teams duplicates effort and increases compliance risk. Companies have a more challenging time delivering training based on role, region, or experience because information on the progress of qualifying study teams and site staff is spread across multiple systems or locations,” said Ayoub.
The lack of transparency makes it hard for sponsors, who are accountable for training, to prove staff is properly trained according to the protocol and create an inspection-ready trial master file, said Ayoub. Because study training is one of the first areas inspected in a trial, Ayoub said sponsors “prioritize the need for clean and current data at the beginning stages.”
Veeva plans to make the training application available for early adopters in the fall of 2022.
Veeva Systems is participating in the DIA Global Annual Meeting, taking place June 19-23 in Chicago. Read here for more information or to attend.